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Posted On: 05/03/2025 9:34:50 AM
Analysis by Perplexity AI:
The p-value for the observed survival outcomes in mTNBC patients treated with leronlimab is approximately 0.0156, indicating statistically significant improvement compared to expected survival rates with standard therapies. This calculation assumes:
Key parameters:
• 30 patients treated (n=30)
• 5 survivors at 48 months (k=5)
• Expected 5% survival rate at 48 months with standard care (p=0.05) [1] [2]
Statistical approach:
• One-sided binomial test comparing observed vs. expected survival
• Uses survival function of binomial distribution:
• Result:
Contextual significance:
1. Expected survival: Historical data shows median overall survival of 11-13 months for mTNBC, with 5-year survival rates ≤11%. The 48-month survival rate with standard therapies is estimated at ≤5%. [1] [2] [5]
2. Observed outcomes: 16.7% survival rate (5/30) at 48 months with leronlimab [4], compared to ≤5% baseline expectation.
3. Clinical implications: This magnitude of survival improvement () suggests leronlimab may provide meaningful clinical benefit, particularly given the heavily pretreated patient population (4 prior lines of therapy). [4] [6]
The results align with CytoDyn’s reported observations of prolonged survival and disease clearance in some patients [3] [4] [6]. Further validation through controlled clinical trials would be needed to confirm these findings.
[1] https://www.nature.com/articles/s41598-021-04316-2
[2] https://pmc.ncbi.nlm.nih.gov/articles/PMC11120599/
[3] https://www.cytodyn.com/newsroom/press-releas...s-in-mtnbc
[4] https://www.pharmanow.live/latest-news/cytody...ancer-2025
[5] https://pmc.ncbi.nlm.nih.gov/articles/PMC9469164/
[6] https://www.clinicaltrialvanguard.com/news/le...-survival/
The p-value for the observed survival outcomes in mTNBC patients treated with leronlimab is approximately 0.0156, indicating statistically significant improvement compared to expected survival rates with standard therapies. This calculation assumes:
Key parameters:
• 30 patients treated (n=30)
• 5 survivors at 48 months (k=5)
• Expected 5% survival rate at 48 months with standard care (p=0.05) [1] [2]
Statistical approach:
• One-sided binomial test comparing observed vs. expected survival
• Uses survival function of binomial distribution:
• Result:
Contextual significance:
1. Expected survival: Historical data shows median overall survival of 11-13 months for mTNBC, with 5-year survival rates ≤11%. The 48-month survival rate with standard therapies is estimated at ≤5%. [1] [2] [5]
2. Observed outcomes: 16.7% survival rate (5/30) at 48 months with leronlimab [4], compared to ≤5% baseline expectation.
3. Clinical implications: This magnitude of survival improvement () suggests leronlimab may provide meaningful clinical benefit, particularly given the heavily pretreated patient population (4 prior lines of therapy). [4] [6]
The results align with CytoDyn’s reported observations of prolonged survival and disease clearance in some patients [3] [4] [6]. Further validation through controlled clinical trials would be needed to confirm these findings.
[1] https://www.nature.com/articles/s41598-021-04316-2
[2] https://pmc.ncbi.nlm.nih.gov/articles/PMC11120599/
[3] https://www.cytodyn.com/newsroom/press-releas...s-in-mtnbc
[4] https://www.pharmanow.live/latest-news/cytody...ancer-2025
[5] https://pmc.ncbi.nlm.nih.gov/articles/PMC9469164/
[6] https://www.clinicaltrialvanguard.com/news/le...-survival/
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